Hermetic stopper for a nozzle

ABSTRACT

A stopper configured to hermetically close a nozzle intended to contain a biopharmaceutical fluid with a cylindrical bore of diameter (D1) and a flange having a groove. The stopper has a body with a front part with a cylindrical outer wall about an axis A, with a diameter at rest greater than (D1), intended to be received under stress in the cylindrical bore of the nozzle, a stop disc extending a rear part of the body radially towards the outside and extending in a plane transverse to the axis. The body and the stop disc are rotationally symmetric about the axis A. The stop disc includes an annular bulge, interposed radially between a first annular shoulder and a second annular shoulder, the bulge extending forward from the stop disc and being intended to be received in the groove in the flange of the nozzle.

TECHNICAL FIELD

The present invention relates to hermetic stoppers for a nozzle, inparticular in the field of containers for biopharmaceutical fluids

BACKGROUND

In the field of biopharmaceutical fluids, as in the field of foodstuffs,the use of “triclamp” type connectors is very common. In this type ofconnection, two similar nozzles are placed face to face with aninterposed gasket, followed by the use of a screw-on cuff(circumferentially tightened hinged collar) with tapered parts tosqueeze the nozzles against each other by compressing the interposedgasket, which creates a hermetic connection.

In certain logistics operations relating to biopharmaceutical fluids, asub-assembly is provided with a hermetically sealed nozzle pending asubsequent connection. This sealed nozzle is formed by a stopper takingthe place of the missing nozzle on which the screw-on cuff is installed,as shown in section in FIG. 8. The screw-on cuff may pose a risk ofdamage by face-to-face contact with plastic bags of biopharmaceuticalfluid, by the same sub-assembly or adjacent sub-assemblies.

Therefore, it has become necessary to provide a simpler solution, whichreduces the risk of damage by contact with plastic bags.

Therefore, to this end, a stopper configured to hermetically close anozzle intended to contain a biopharmaceutical fluid is proposed; saidnozzle having a cylindrical bore of diameter D1 and a flange with agroove, the stopper comprising:

-   -   a body comprising a front part with a cylindrical outer wall        about an axis A, with a diameter at rest substantially greater        than, intended to be received under stress in the cylindrical        bore of diameter D1 of the nozzle,    -   a stop disc, extending a rear part of the body at least radially        towards the outside and generally extending in a plane        transverse to the axis,

the body and the stop disc being rotationally symmetric about the axisA,

the stop disc comprising an annular bulge, interposed radially between afirst annular shoulder and a second annular shoulder, the bulgeextending forward from the stop disc and being intended to be receivedin the groove in the flange of the nozzle,

such that when the stopper is inserted into the nozzle, two hermeticbarriers are formed between an internal space of the nozzle and theexternal environment, namely a first barrier at the wall of the body ofthe stopper received in the internal bore and a second barrier at themating point of the bulge in the groove.

Advantageously, the use of a triclamp connector type cuff is avoided.The use of a gasket is also avoided, as the bulge acts, at least inpart, as a gasket.

Such a stopper has a modest, or even very attractive cost price and, asa result, may be a single-use part.

In various embodiments of the invention, use may also possibly be madeof one and/or the other of the following arrangements, alone or incombination.

According to one aspect, the body and the stop disc may be formedintegrally in a single part in an elastomeric material. It is preferablypossible to use a silicone or a TPE (thermoplastic elastomer), forexample, for this single material part. However, other bases are notexcluded, such as polyurethane, polyester, polyethylene, polypropylene,polyurethane or polyamide type copolymers.

According to one aspect, a sufficiently elastic material, which providesflexibility such that the hardness of the body of the stopper is lessthan Shore 70A, is chosen.

According to one aspect, a sufficiently elastic material, which providesflexibility such that the hardness of the body of the stopper is between50A and 80A Shore, is chosen.

According to one aspect, the stopper may be formed as a bi-material partin silicone or TPE, with a first portion made from a first material anda second portion made from a second material, the first material beingmore flexible than the second material. The first material may be asilicone or a TPE (thermoplastic elastomer) the second material may be apolypropylene, a polyamide or a polybutylene terephthalate.

According to one aspect, the cylindrical outer wall of the front part,as well as the annular bulge, may be formed in the first portion. A goodcontact is thus obtained, which forms a hermetic barrier. The body isflexible and peripheral retaining means more rigid.

According to one aspect, provision may also be made for peripheralretaining means extending the stop disc at least forward with a returntowards the axis in order to rest on the rear of the flange.

This increases the effectiveness of the second barrier. Furthermore,this prevents accidental removal, strengthens the hold obtained byinsertion under stress of the body.

According to one aspect, the peripheral retaining means are formed by acontinuous circumferential annular rim. This forms a completelyrotationally symmetric configuration about the axis A.

According to one aspect, the peripheral retaining means are formed byretaining claws arranged circumferentially discontinuously.Advantageously, such claws may be deformed more easily, the claws mayreturn much further towards the axis than the annular rim.

According to one aspect, the retaining claws may be formed integrally orin another material, with a predefined number of claws, for example,two, three or four. Depending on the configuration and the client'srequirements, it is thus possible to adjust the retaining force impartedby the retaining device.

According to one aspect, the bulge extends annularly at a diameter D3 ofbetween 18 mm and 40 mm. This covers the standard dimensions, which are¾ inch and 1.5 inches.

According to one aspect, the bearing interface between the body of thestopper and the bore extends over an axial length L1 of at least 3 mm,and preferably at least 6 mm, and preferably at most 10 mm. A largebearing surface is thus formed for sealing and mechanical retention.

According to one aspect, provision is made for the width and depth ofthe groove 23 to substantially correspond to the width and projection ofthe bulge, in order to thus obtain a correspondence in shape between thebulge and groove. This ensures that the second barrier is properlyeffective.

According to one aspect, as regards dimensional conditions, provisionmay be made for D1′ to be between 1.05 D1 and 1.25 D1 or for D1′ to bebetween D1+1 mm and D1+5 mm. Depending on the type of silicone material,the compression ratio may be more or less significant. It is possible tochoose a ratio D1′=1.20 D1. This represents a good compromise betweenthe moderate insertion force and a good hold and a good seal.

According to one aspect, provision is made for a non-use control flange,with a front ring and a rear ring and one or more fusible zones joiningthe front ring to the rear ring. Thus, following installation of thestopper, the use control flange is added and this ensures that the fluidcontained in the nozzle and/or the associated container has not beenopened and in contact with fresh air.

According to one aspect, a gripping device, in the form of a tongue orhandle, is provided. This facilitates removal of the stopper forsubsequent permitted use of the biopharmaceutical fluid. Provision maybe made for the gripping device to be squeezed between two fingers inorder for it to then be pulled axially towards the rear of the stopper.

According to one aspect, the gripping device protrudes backward from thestop disc of the stopper. In particular, the gripping device may beformed integrally with the body of the stopper, it may be in a centralaxial position.

Finally, the present invention also relates to an assembly comprising,on the one hand, a nozzle (2) intended to contain a biopharmaceuticalfluid, said nozzle having a cylindrical bore (21) of diameter D1 and aflange with a groove (23) and, on the other hand, a stopper as describedabove. In particular, the assembly in question may contain a bag of highadded value biopharmaceutical products, a filter, other tubes andnozzles, etc.

BRIEF DESCRIPTION OF THE DRAWINGS

Other aspects, aims and advantages of the invention will become apparenton reading the following description of an embodiment of the invention,provided by way of a non-limiting example. The invention will also bebetter understood in relation to the appended drawings, in which:

FIG. 1A is a general sectional view of a stopper according to a firstembodiment of the invention,

FIG. 1B is a general front view of the stopper in FIG. 1,

FIG. 2 is a sectional view of another embodiment,

FIG. 3 is a sectional view of yet another embodiment,

FIG. 4 is a sectional view of yet another embodiment,

FIG. 5 is a sectional view of yet another embodiment,

FIG. 6 is a sectional view of yet another embodiment,

FIG. 7 is a sectional view of yet another embodiment,

FIG. 8 shows the prior art.

DESCRIPTION OF EMBODIMENTS

In the different figures, the same references relate to identical orsimilar components. For reasons of clarity, certain components cannot berepresented to scale.

FIG. 8 shows a conventional solution for which it is necessary tohermetically seal a nozzle 2. In the example illustrated, a flexibletube 3 is connected to said nozzle 2. The nozzle, stopper and tube formpart of assembly intended to contain a biopharmaceutical fluid. Such anassembly may comprise one or more bags, one or more filters, one or moretubes, one or more stop valves, etc.

An O-ring 85 or, alternatively, a flat gasket with a bulge 83 is placedon the face of the nozzle, then a stopper identified as 81 is placedover the top. A closure with cuffs 84 is then installed and the screw 82is tightened to squeeze the cuff and, thanks to the bevelled shapes, toapply an axial pressure on the gasket to ensure a good level of sealing.

FIGS. 1A and 1B show a first embodiment of the invention. There is anozzle 2 with conventional dimensions in the field of biopharmaceuticalfluids. For example, the internal diameter of the nozzle may range from10 mm to 30 mm and the length of the nozzle may range from 10 mm to 50mm.

In the example illustrated, a flexible tube 3 is inserted into the rearpart of the nozzle as recognised in itself. The front part of the nozzlecomprises a tubular body with a cylindrical bore 21 of diameter D1 and aflange 28 generally extending in a plane transverse to the axis Aradially towards the outside. The flange 28 comprises a groove 23,intended to receive a component forming a gasket.

The groove 23 extends annularly at a diameter D3 of between 18 mm and 40mm. In particular, two specific values are considered for the diameterD3 namely three quarters of an inch and one and a half inches (¾ inchand 1.5 inches).

The present invention provides a stopper 1, which will form a singlepart for hermetically sealing the nozzle 2 and thus replacing thesolution illustrated in FIG. 8. The stopper 1 may be envisaged as asingle-use part, namely that is not recycled following shipment of thebiopharmaceutical assembly for a client.

In another configuration, the stopper may effectively be recycled,sterilised and used several times.

In the terminology used throughout the present document, it should benoted that the terms front and rear are used relative to an insertiondirection of a component, in this case insertion of the stopper 1 intothe nozzle 2. The directions front and rear appear in FIGS. 2, 5 and 6and apply similarly to other embodiments.

The stopper comprises a body 10 comprising a front part 10A and a rearpart 10B.

The front part 10A comprises an outer wall 11, which is cylindricalabout an axis A.

The front part 10A has a diameter at rest Dr substantially greater thanD1. According to one example, Dr may be between 1.05 D1 and 1.25 D1;according to another example, D1′ may be between D1+1 mm and D1+5 mm.D1′ may be close to 1.2 D1.

The front part 10A is intended to be received under stress in thecylindrical bore 21 of the nozzle 2.

The stopper 1 comprises a stop disc 12, extending a rear part 10B of thebody at least radially towards the outside and generally extending in aplane P transverse to the axis A.

The external diameter of the stopper identified as D5 may be between1.6×D1 and 2×D1.

The stop disc 12 comprises a first annular shoulder 15, which extends ina plane P transverse to the axis A and a second annular shoulder 16situated radially further outside, in the same transverse plane P.

The stop disc 12 comprises an annular bulge 13, interposed radiallybetween the first annular shoulder 15 and the second annular shoulder16.

The annular bulge 13 is intended to be received in the groove 23 of theflange 28 of the nozzle 2. The annular bulge 13 generically forms acomponent forming a gasket.

On the flange of the nozzle, provision is made for a first bearingsurface 25 facing the first annular shoulder 15 of the stopper and asecond bearing surface 26 facing the second annular shoulder 16 of thestopper.

Moving towards the outside, the stop disc is extended by a return rimidentified as 14, which extends forward.

In certain embodiments, provision is made for peripheral retainingmeans, to secure the position of the stopper once installed on thenozzle 2.

In the example illustrated in FIG. 1, the peripheral retaining means areformed as retaining claws 18.

In the example illustrated, four retaining claws are shown regularlyspaced around the circumference of the return rim 14 of the stopper.

Naturally, the number of retaining claws may differ, there may be 2, 3or any number equal to or greater than 5.

In FIG. 2, the stopper does not have a retaining flange, which may beenvisaged where the stopper's retention in the nozzle is sufficientlyensured by friction and the residual stress between the two parts onceassembly has been completed.

The engagement length L1 of the body inside the bore 21, as well as theresidual radial stress following insertion, may be such that retentionis sufficient for certain applications.

According to one example, the engagement length L1 of the body insidethe bore 21 may be equal to at least 3 mm, according to another example,the engagement length L1 may be equal to at least 5 mm, up to 10 mm.

The traction force for removing the stopper may be calibrated to begreater than 30 Newtons. This value may be considered for all healthembodiments.

It should be noted that the front part 10A of the body of the stoppermay comprise an inlet chamfer 31, which facilitates the start ofinsertion of the stopper 1 into the nozzle 2.

FIG. 2 shows that a gripping device 50 may also be provided. Thisgripping device 50 may take the form of a handle or tongue. A user maysqueeze the gripping device between two fingers to then pull it axiallytowards the rear of the stopper; which makes it easier to remove thestopper for subsequent permitted use of the biopharmaceutical fluid.

The gripping device 50 protrudes backward from the stop disc 12 of thestopper. The gripping device 50 may protrude backward, for example, by adimension of at least 10 mm.

The gripping device 50 may be formed integrally with the body of thestopper, it may be in a central axial position.

FIG. 3 shows a variant of the nozzle, which comprises a bore of a smalldiameter D1 with a longer length and an enlargement of diameter D2 justbefore the flange 28. In this case, the hermetic contact between thestopper and the nozzle is made at the small diameter D1.

In this example, peripheral retaining means are shown formed by anexternal continuous circumferential annular rim 19. This externalannular rim has an external chamfer, which aids its insertion into thenozzle, sufficient radial deformation is provided to enable the annularrim to pass the maximum external diameter of the nozzle.

FIG. 4 shows another variant of the nozzle, which has a bore of internaldiameter D1 over its entire axial length. D1 has a value greater thanthat in FIG. 3.

FIG. 5 shows another variant of the stopper made from two materials. Thepart above the axis line shows an example of material forming, while thepart below the axis line shows another example.

The stopper 1 is formed as a bi-material part with a first portion M1made from a first material, for example from silicone or a thermoplasticelastomer, and a second portion M2 made from a second material, thefirst material being more flexible than the second material.

For the second material M2, it is possible to choose polyurethane,polyester, polyethylene, polypropylene, polyurethane or polyamidecopolymer type bases.

In the upper section of FIG. 5, the flexible material M1 forms thecylindrical outer wall 11 of the body of the stopper, as well as thebulge 13 and the bearing surfaces 15, 16 that surround it. It is notedthat once the stopper is installed in the nozzle, the first material M1is not accessible from the outside, only the components formed by thesecond material are.

In the lower section of FIG. 5, the flexible material M1 forms the bulge13 and the bearing surfaces 15, 16 that surround it, but the body 11 ofthe stopper 1 is formed from the second material M2.

In the exemplary embodiment in FIG. 7, provision is made for a non-usecontrol flange 4, with a front ring 41 and a rear ring 42 and one ormore fusible zones 44 joining the front ring to the rear ring.

In order to insert the flange in question, for example, a thermalprocess is provided, with heating of the flange, which has a moreelastic shape in this case, while after cooling its elasticity will havedecreased and the only solution for removing it from the peripheral rim14 will be to break the fusible areas 44.

1. A stopper configured to hermetically close a nozzle intended tocontain a biopharmaceutical fluid, said nozzle having a cylindrical boreof diameter (D1) and a flange with a groove, the stopper comprising: abody comprising a front part with a cylindrical outer wall about an axisA, with a diameter at rest (D1′) substantially greater than (D1),intended to be received under stress in the cylindrical bore of thenozzle, a stop disc, extending a rear part of the body at least radiallytowards the outside and generally extending in a plane transverse to theaxis, the body and the stop disc being rotationally symmetric about theaxis A, the stop disc comprising an annular bulge, interposed radiallybetween a first annular shoulder and a second annular shoulder, thebulge extending forward from the stop disc and being intended to bereceived in the groove of the flange of the nozzle, such that at leasttwo hermetic barriers are formed between an internal space of the nozzleand the external environment, namely a first barrier at the wall of thebody received in the internal bore and a second barrier at the matingpoint of the bulge in the groove.
 2. The stopper according to claim 1,wherein the body and the stop disc are formed integrally in a singlepart in an elastomeric material.
 3. The stopper according to claim 1,formed as a bi-material part in silicone or thermoplastic elastomer,with a first portion (M1) made from a first material and a secondportion (M2) made from a second material, the first material being moreflexible than the second material.
 4. The stopper according to claim 3,wherein the cylindrical outer wall of the front part, as well as theannular bulge, are formed in the first portion (M1).
 5. The stopperaccording to claim 1, wherein provision is also made for peripheralretaining means extending the stop disc at least forward with a returntowards the axis in order to rest on the rear of the flange.
 6. Thestopper according to claim 5, wherein the peripheral retaining means areformed by an external continuous circumferential annular rim.
 7. Thestopper according to claim 5, wherein the peripheral retaining means areformed by retaining claws arranged circumferentially discontinuously. 8.The stopper according to claim 1, wherein the bearing interface betweenthe body of the stopper and the bore extends over an axial length L1 ofat least 3 mm.
 9. The stopper according to claim 1, wherein provision ismade for a non-use control flange, with front ring and a rear ring andone or more fusible zones joining the front ring to the rear ring. 10.The stopper according to claim 1, wherein provision is made for agripping device, in the form of a tongue or handle.
 11. The stopperaccording to claim 10, wherein the gripping device protrudes backwardfrom the stop disc of the stopper.
 12. An assembly comprising, on theone hand, a nozzle intended to contain a biopharmaceutical fluid, saidnozzle having a cylindrical bore of diameter D1 and a flange with agroove and, on the other hand, a stopper according to claim
 1. 13. Thestopper according to claim 4, wherein provision is also made forperipheral retaining means extending the stop disc at least forward witha return towards the axis in order to rest on the rear of the flange.14. The stopper according to claim 8, wherein provision is made for anon-use control flange, with front ring and a rear ring and one or morefusible zones joining the front ring to the rear ring.
 15. The stopperaccording to claim 9, wherein provision is made for a gripping device,in the form of a tongue or handle.